Looking for a SCRA freelance opportunity.
SCRA Home Based Haacht Belgium
Since September 2012
SCRA Phase 1 and 2 trials oncology, Phase 1 and 2 trial ophthalmology (with 5 months monitoring in UK), Phase 3 trial Cat allergy, Phase 2 trial urology. Performing feasibilities and Study Start Up tasks, CEC submissions.
Nurse Haacht Belgium
October 2009 --- June 2012
SCRA, Lead SRP Home based Haacht Belgium
October 2000 --- September 2009
Phase 1 to 3 trials from feasibility to study close out.
Mentor function in training of Junior CRA's.
Site Regulatory Package Reviewer and SRP Lead, writing SRP guidelines and FU international status of SRP approvals.
ICF reviewer for Belgium.
Study Nurse Endocrinology UZ Gasthuisberg Leuven, Belgium
November 1996 --- September 2000
Study Nurse Endocrinology including Diabetes Mellitus, Growth Hormone Deficiency, Thyroid Diseases, Andrology and Lipid Studies under supervision of Prof. Mathieu.
Nurse UZ Gasthuisberg, Oncology Surgery Unit Nursing
August 1993 --- October 1996
Breast Cancer, Abdominal and Skin cancer, Supervision Prof. De Wever and Prof. Christiaens.
Nurse Boutersem, Belgium
July 1991 --- August 1993
Nurse UZ Gasthuisberg, Leuven, Belgium
July 1986 --- July 1991
Intensive Care Unit
ApproachabilitySociabilitySelf-disciplineProblem solvingProactivityOrganizationInterest in knowledgeIndependenceFlexibilityEfficiencyCritical thinkingCoordinationCollaborationAttention to detailStrategic thinking
Diabetes Phase IAllergy and immunologyCancerCardiovascular diseasesClinical monitoringClinical researchClinical trialsColorectal surgeryContract negotiationCTMSAnesthesiaData entryData ManagementElectronic Data Capture (EDC) EndocrinologyEndocrinology and metabolismEnglishEthics submission and approval processGastroenterologyGCPGeriatric medicineICH-GCPInfectious diseasesInformed Consent ProcessMedical oncology Microsoft OfficeNeurologyoncologyOperating RoomOphthalmologyOrthopedicPatient Screening and RecruitmentPharmaceutical IndustryPhase IPhase IIPhase IIIPhase IVPulmonary diseasesQualificationRandomization and blindingRandomization SystemsRegulatory RequirementsRheumatologySerious Adverse Event (SAE)SOPTeam LeadershipUrologyVascular surgeryVerificationInformed Consent DocumentsWriting Study Procedures and SOPsUnderstanding of regulatory guidelines
Skills and Expertise
Serious Adverse Event (SAE) ReconciliationShipment of biological specimenSite managementSolve problemsTrain on site staffVerify dataWork under specific instructions Analyze data Design case record forms Interact with nurses Interact with physiciansAdverse event reportingApprove consent documentsApprove monitoring reportsApprove queriesArchive documentationArchive study documentsAssess site feasibilityAssist study siteAttend investigator meetingClinical data collectionCoachCollaborate with principal investigatorCollaborate with project teamCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Complete study proceduresConduct close-out visitsConduct monitor visitsConduct site initiationConduct the trialConfocal microscopyContact potential subjectsCreate study documentsData entryData verificationDesign case record form (CRF)Design subject consent formEthics committee submissionsFollow-up of external auditsFollow-up of internal auditsGastrointestinal diseasesIdentify investigatorsIndentify sitesInformed consent processInitiation visitInteract with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansMonitor a clinical studyMonitor clinical trials Monitor dataMonitoring enrolmentMonitoring subject complianceNegotiate budget Oral presentationPatient recruitmentPre-study procedures Preparing referral lettersProvide trainingRegulatory documentationReport serious adverse events (SAE)Resolves queriesRespond to audit findingsRetrieve study documentsReview exclusion criteriaReview inclusion criteriaReview monitoring reportsReview queriesSchedule trial visitsScreen patientsSelect investigators
Bachelor in Nurse from Hoger Rijksinstituut Paramedische Beroepen, Mechelen in 1986
Training and Certification
GCP for Investigators, Brookwood International Academy in 1997 Certification
Certificate Intensive Care in 1988 Certification